DepressionPhase 4VorDe-PDNCT04301492
Tolerability, Safety and Efficacy of Vortioxetine
A Phase 4 study testing Vortioxetine in people with Depression, run by IRCCS San Raffaele Roma at 2 sites in Italy.
Trial summary
Depression is a psychiatric disorder frequently found in Parkinson's disease (MP), affecting approximately 40-50% of patients and assuming the characteristics of major depression in 17% of cases. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Depression
- What is being tested?
- Vortioxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesItaly
- Study dates
- 20 Nov 2019to 30 Jul 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Male and female of every ethnic group, age 30 to 80 years
- Diagnosis of Parkinson's disease according UK Brain Bank Criteria
- Hoehn \&Yahr: stage 1 to 3
- Patients with diagnosis of sustained depression
- Hamilton Depression Rating Scale score (HAM-D-17) ≥ 14
- Beck Depression Inventory score (BDI)≥13
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- Stable doses of antiparkinsonian drugs for at least 4 weeks.
- Patients able to understand and provide written informed consent
- Female patients in post-menopausal state with at least one year absence of vaginal bleeding or spotting or be surgically sterile
- Women of childbearing potential must use an acceptable method of contraception
- Men with a potentially fertile partner must have had a vasectomy or be willing to use an acceptable method of contraception for the duration of the study
Who cannot join
- • Atypical Parkinsonism.
- Subjects at risk of suicide (with a score ≥ 3 at the Item 3 of the HAM-D-17)
- Any significant psychiatric, metabolic and systemic significant concomitant disease
- Patients with clinically significant out of range laboratory values
- Patients with history of epileptic seizures
- Subjects with Dopa Dysregulation Syndrome (DDS)
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- Subjects treated with irreversible IMAO and IMAO-A
- Use of vortioxetine in the past 30 days
- Patient treated with oral anticoagulant
- Patients participating in a clinical trial in the last 6 weeks
- Patients with moderate-severe cognitive decline not able to provide consent form
- Patients currently lactating or pregnant or planning to become pregnant during the duration of the study
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS San Raffaele
Roma, 00163
Fabrizio Stocchi, MD PhD, +390652252311, fabrizio.stocchi@sanraffaele.it
Laura Vacca, MD PhD, +390652252311, laura.vacca@sanraffaele.it
- Recruiting
IRCCS San Raffaele Roma
Rome, 00163
laura vacca, +390652252311, laura.vacca@sanraffaele.it
About this study
Official title: Tolerability, Safety and Efficacy of Vortioxetine for Treatment od Depression in Parkinson's Disease: a 16 Week Open Label Study
Depression is a psychiatric disorder frequently found in Parkinson's disease (MP), affecting approximately 40-50% of patients and assuming the characteristics of major depression in 17% of cases. Vortioxetine is a new antidepressant, which inaugurates the class of "multimodal" antidepressants, able to exert modulation of serotonergic receptors, inhibit serotonin reuptake, modulate other neurotransmitters such as norepinephrine, dopamine, acetylcholine and histamine.
The primary endpoint of this study will be to verify safety and tolerability of vortioxetine in the treatment of sustained depression in PD. Safety will be assessed through the recording of treatment emergent adverse events (TEAE) and vital signs in each study visits and laboratory tests, ECG, physical and neurological examination at baseline and End of study. The non worsening of motor disability evaluated through Unified Parkinson's Disease Rating Scale (UPDRS) will be the tolerability end point.
The secondary endpoint will be to demonstrate the efficacy on depression: efficacy measures will include Hamilton Depression Rating Scale (HAM-D-17), Beck Depression Inventory (BDI), CGI-S and CGI-I.
Read the detailed description
Depression is a psychiatric disorder frequently found in Parkinson's disease (MP), affecting approximately 40-50% of patients and assuming the characteristics of major depression in 17% of cases. Depression can also precede the onset of motor symptoms, playing an important role in the clinical course of the disease. Indeed, the presence of depression has been associated with greater disability, a more rapid cognitive decline, a higher mortality and a heavier burden for families and caregivers.The mechanisms underlying depression in MP are still not completely clarified, but autopsy and functional anatomy studies have demonstrated the presence of alterations in the limbic system and in noradrenergic and serotonergic nuclei of the brainstem.This dual nature accounts for the partial ineffectiveness of the common antidepressants that do not target alterations of the dopaminergic system.
Vortioxetine is a new antidepressant, which inaugurates the class of "multimodal" antidepressants, able to exert modulation of serotonergic receptors, inhibit serotonin reuptake, modulate other neurotransmitters such as norepinephrine, dopamine, acetylcholine and histamine.
Currently, tricyclic antidepressants and selective serotonin reuptake inhibitors represent the most common pharmacotherapy for depression treatment in PD patients. Although, they can induce or increase motor disability and other PD symptoms. It is of paramount importance finding a novel therapeutic approach able to positively impact on depression without worsening motor dysfunction. Therefore Vortioxetine can represent an innovative drug in the treatment of depression in PD thanks to its ability to increase dopaminergic neurotransmission in brain structures usually associated with depression.
This is a pilot, single centre, open label, ITT study which will be conducted at the l'IRCCS San Raffaele Pisana, under the responsibility of Fabrizio Stocchi, Principal Investigator.
The study will be conducted in accordance with the guidelines for Good Clinical Practice, in line with the law on the processing of patients' personal data and the principles of the Helsinki Declaration.
Patients will receive informed consent before they are included in the study.
Study population will include patients with idiopathic Parkinson's disease in stage I-III of the disease, suffering from sustained depression. 20 consecutive PD outpatient referred to the center for the study of Parkinson's disease and movement disorders of the IRCCS San Raffaele Pisana will be enrolled.
Since this is a pilot, monocentric study, calculation of the sample size is not required.
- Conditions
- Depression
- Being tested
- Vortioxetine
- Keywords
- vortioxetine, tolerability, safety, parkinson's disease
- Medical subject headings
- Depression, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
16 weeks for each participant. During the first visit a collection of medical and pharmacological history will be collected and ECG, laboratory tests and clinical assessment will be performed. After verifying the absence of significant abnormalities at the ECG and laboratory tests and after confirming all inclusion and exclusion criteria, subjects will perform the second visit to receive study drug (Brintellix drops 20 mg/ml). All subjects will be instructed to take Vortioxetine 1 drop every day after lunch, increasing of 1 drop per day arriving to 10 drops per day. After 5 days from the beginning of treatment, subject will be contacted by phone to check on tolerability and in absence of side effects, the dosage will be increased to 10 drops per day. At Week 4-8-12 patients will return to the site to perform all clinical evaluations required and to receive study drug.
| Study group | Role | What they receive |
|---|---|---|
| Vortioxetine | Experimental | first visit medical and pharmacological history will be collected and ECG, laboratory tests and clinical assessment will be performed. After verifying the absence of significant abnormalities at the ECG and laboratory tests and after confirming all inclusion and exclusion criteria, subjects will perform the second visit (Week 1 - Visit 2) to receive study drug (Brintellix drops 20 mg/ml). All subjects will be instructed to take Vortioxetine 1 drop every day after lunch, increasing of 1 drop per day arriving to 10 drops per day. After 5 days from the beginning of treatment, subject will be contacted by phone to check on tolerability and in absence of side effects, the dosage will be increased to 10 drops per day (Visit 3- Phone contact). At Week 4-8-12 (Visits 4-5-6) patients will return to the site to perform all clinical evaluations required and to receive study drug. Visit 7 subjects will return to the site to perform all the assessment required by protocol. Receives: Drug: Vortioxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The primary endpoint of this study will be to verify tolerability and safety of vortioxetine in the treatment of sustained depression in PD. The non worsening of motor disability evaluated through Unified Parkinson's Disease Rating Scale (UPDRS) will be the tolerability end point.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Incidence of Vortioxetine in the decrease of depression
The secondary endpoint will be to demonstrate the efficacy on depression: efficacy measure will include Hamilton Depression Rating Scale
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start20 Nov 2019
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301492
- Sponsor's protocol ID
- VorDe-PD
- Other IDs
- 2018-004112-21, 2018
- Acronym
- VorDe-PD
- Status last verified
- Jun 2023
- First submitted
- 17 Feb 2020
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after the end of sudy
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability, Safety and Efficacy of Vortioxetine for Treatment od Depression in Parkinson's Disease: a 16 Week Open Label Study
- ClinicalTrials.gov ID
- NCT04301492
- Acronym / sponsor ID
- VorDe-PD / VorDe-PD
- Conditions
- Depression
- Keywords
- vortioxetine, tolerability, safety, parkinson's disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Depression is a psychiatric disorder frequently found in Parkinson's disease (MP), affecting approximately 40-50% of patients and assuming the characteristics of major depression in 17% of cases. Vortioxetine is a new antidepressant, which inaugurates the class of "multimodal" antidepressants, able to exert modulation of serotonergic receptors, inhibit serotonin reuptake, modulate other neurotransmitters such as norepinephrine, dopamine, acetylcholine and histamine.
The primary endpoint of this study will be to verify safety and tolerability of vortioxetine in the treatment of sustained depression in PD. Safety will be assessed through the recording of treatment emergent adverse events (TEAE) and vital signs in each study visits and laboratory tests, ECG, physical and neurological examination at baseline and End of study. The non worsening of motor disability evaluated through Unified Parkinson's Disease Rating Scale (UPDRS) will be the tolerability end point.
The secondary endpoint will be to demonstrate the efficacy on depression: efficacy measures will include Hamilton Depression Rating Scale (HAM-D-17), Beck Depression Inventory (BDI), CGI-S and CGI-I.
Detailed description
Depression is a psychiatric disorder frequently found in Parkinson's disease (MP), affecting approximately 40-50% of patients and assuming the characteristics of major depression in 17% of cases. Depression can also precede the onset of motor symptoms, playing an important role in the clinical course of the disease. Indeed, the presence of depression has been associated with greater disability, a more rapid cognitive decline, a higher mortality and a heavier burden for families and caregivers.The mechanisms underlying depression in MP are still not completely clarified, but autopsy and functional anatomy studies have demonstrated the presence of alterations in the limbic system and in noradrenergic and serotonergic nuclei of the brainstem.This dual nature accounts for the partial ineffectiveness of the common antidepressants that do not target alterations of the dopaminergic system.
Vortioxetine is a new antidepressant, which inaugurates the class of "multimodal" antidepressants, able to exert modulation of serotonergic receptors, inhibit serotonin reuptake, modulate other neurotransmitters such as norepinephrine, dopamine, acetylcholine and histamine.
Currently, tricyclic antidepressants and selective serotonin reuptake inhibitors represent the most common pharmacotherapy for depression treatment in PD patients. Although, they can induce or increase motor disability and other PD symptoms. It is of paramount importance finding a novel therapeutic approach able to positively impact on depression without worsening motor dysfunction. Therefore Vortioxetine can represent an innovative drug in the treatment of depression in PD thanks to its ability to increase dopaminergic neurotransmission in brain structures usually associated with depression.
This is a pilot, single centre, open label, ITT study which will be conducted at the l'IRCCS San Raffaele Pisana, under the responsibility of Fabrizio Stocchi, Principal Investigator.
The study will be conducted in accordance with the guidelines for Good Clinical Practice, in line with the law on the processing of patients' personal data and the principles of the Helsinki Declaration.
Patients will receive informed consent before they are included in the study.
Study population will include patients with idiopathic Parkinson's disease in stage I-III of the disease, suffering from sustained depression. 20 consecutive PD outpatient referred to the center for the study of Parkinson's disease and movement disorders of the IRCCS San Raffaele Pisana will be enrolled.
Since this is a pilot, monocentric study, calculation of the sample size is not required.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vortioxetine | Experimental | Drug: Vortioxetinefirst visit medical and pharmacological history will be collected and ECG, laboratory tests and clinical assessment will be performed. After verifying the absence of significant abnormalities at the ECG and laboratory tests and after confirming all inclusion and exclusion criteria, subjects will perform the second visit (Week 1 - Visit 2) to receive study drug (Brintellix drops 20 mg/ml). All subjects will be instructed to take Vortioxetine 1 drop every day after lunch, increasing of 1 drop per day arriving to 10 drops per day. After 5 days from the beginning of treatment, subject will be contacted by phone to check on tolerability and in absence of side effects, the dosage will be increased to 10 drops per day (Visit 3- Phone contact). At Week 4-8-12 (Visits 4-5-6) patients will return to the site to perform all clinical evaluations required and to receive study drug. Visit 7 subjects will return to the site to perform all the assessment required by protocol. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- • Male and female of every ethnic group, age 30 to 80 years
Key exclusion criteria (12 listed)
- • Atypical Parkinsonism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vortioxetine16 weeks for each participant. During the first visit a collection of medical and pharmacological history will be collected and ECG, laboratory tests and clinical assessment will be performed. After verifying the absence of significant abnormalities at the ECG and laboratory tests and after confirming all inclusion and exclusion criteria, subjects will perform the second visit to receive study drug (Brintellix drops 20 mg/ml). All subjects will be instructed to take Vortioxetine 1 drop every day after lunch, increasing of 1 drop per day arriving to 10 drops per day. After 5 days from the beginning of treatment, subject will be contacted by phone to check on tolerability and in absence of side effects, the dosage will be increased to 10 drops per day. At Week 4-8-12 patients will return to the site to perform all clinical evaluations required and to receive study drug. | Drug | Vortioxetine |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: through study completion, an average of 1 year
The primary endpoint of this study will be to verify tolerability and safety of vortioxetine in the treatment of sustained depression in PD. The non worsening of motor disability evaluated through Unified Parkinson's Disease Rating Scale (UPDRS) will be the tolerability end point.
1 secondary outcome
Incidence of Vortioxetine in the decrease of depression
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Yes. after the end of sudy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vortioxetine in people with Depression, run by IRCCS San Raffaele Roma at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fabrizio stocchi, MD PhD (+39 0652252311, fabrizio.stocchi@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.